Departamento de Farmacia, Tecnología Farmacéutica y Físico Química, Facultad de Farmacia y Ciencias de la Alimentación. Universidad de Barcelona. Avda. Joan XXIII, 27-31. 08028 Barcelona, Spain.
Fundación Idonial. Parque Científico y Tecnológico de Gijón. Avda. Jardín Botánico, 1345. 33203 Gijón, Asturias, Spain.
Int J Pharm. 2023 Aug 25;643:123289. doi: 10.1016/j.ijpharm.2023.123289. Epub 2023 Aug 2.
The production of 3D printed pharmaceuticals has thrived in recent years, as it allows the generation of customised medications in small batches. This is particularly helpful for patients who need specific doses or formulations, such as children. Compounding pharmacies seek alternatives to conventional solid oral doses, opting for oral liquid formulations. However, ensuring quality and stability, especially for pH-sensitive APIs like omeprazole, remains a challenge. This paper presents the application of semi-solid extrusion 3D printing technology to develop patient-tailored medicinal gummies, with an eye-catching appearances, serving as an innovative omeprazole pharmaceutical form for paediatric use. The study compares 3D printing hydrogels with dissolved omeprazole to hydrogels loaded with gastro-resistant omeprazole pellets, a ground-breaking approach.. Gastro-resistance and dissolution profiles were studied using different methods for better comparison and to emphasize the significance of the assay's methodology. Both developed formulas exhibit proper rheology, good printability, and meet content and mass uniformity standards. However, the high gastro-resistance and suitable release profile of 3D printed chewable semi-solid doses with enteric pellets highlight this as an effective strategy to address the challenge of paediatric medication.
近年来，3D 打印制药技术蓬勃发展，因为它可以在小批量生产定制药物。这对于需要特定剂量或配方的患者特别有帮助，例如儿童。复方药剂师寻求替代传统的固体口服剂量，选择口服液体配方。然而，确保质量和稳定性，特别是对于像奥美拉唑这样的 pH 敏感 API，仍然是一个挑战。本文介绍了半固态挤出 3D 打印技术在开发患者定制的药用软糖中的应用，这种软糖外观引人注目，是一种创新的奥美拉唑儿科药物形式。该研究比较了 3D 打印水凝胶与溶解的奥美拉唑和负载胃耐奥美拉唑丸的水凝胶，这是一种开创性的方法。使用不同的方法研究了胃耐和溶解曲线，以进行更好的比较，并强调了该测定方法的重要性。两种开发的配方均表现出适当的流变学特性、良好的可印刷性，并符合含量和质量均匀性标准。然而，具有肠溶丸的 3D 打印咀嚼半固态剂量的高胃耐和合适的释放曲线突出了这是解决儿科药物挑战的有效策略。
